Follistatin Levels in Metabolically Healthy and Unhealthy Obese Individuals

NCT ID: NCT06229899

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2023-01-15

Brief Summary

There is no clear boundary on which obese individuals should be considered metabolically healthy and which should be considered metabolically unhealthy. It is also not very clear whether the individuals who are considered metabolically healthy will remain healthy in the future. The objective of this study was to assess potential disparities in serum follistatin levels between these two distinct groups. Furthermore, the study sought to investigate whether this disparity could serve as a reliable indicator for distinguishing between metabolically healthy and unhealthy obese individuals.

Detailed Description

Individuals with similar body mass indexes may have different metabolic health and cardiovascular risks. Research shows that some individuals with comparable body mass index (BMI) are metabolically healthy and have a lower risk of cardiovascular issues, while others are metabolically unhealthy and have a higher risk. Studies indicate that the lifestyles of metabolically healthy and unhealthy obese individuals, such as diet, physical activity, and sleep patterns, do not differ significantly, even though the individuals have similar levels of total or subcutaneous adiposity. However, it has been shown that metabolically healthy obese individuals tend to have lower levels of visceral adiposity compared to unhealthy ones.

Patients with BMI≥30, who applied to the internal medicine clinic, were included in the study. Among these patients, those without criteria of metabolic syndrome other than an increase in waist circumference (blood pressure ≥130/85 mmHg, fasting blood sugar ≥100 mg/dl, triglycerides ≥150 mg/dl, HDL-cholesterol <40 mg/dl in men and <50 mg/dl in women) and without prediabetes were defined as metabolically healthy obese individuals. Those with at least 1 metabolic syndrome criterion other than an increase in waist circumference were classified as metabolically unhealthy obese individuals. The participants' fasting blood sugar levels, HbA1c levels, insulin levels, lipid panel results, liver enzymes levels,urea levels, creatinine levels, whole blood count, and thyroid hormones were examined. Anthropometric measurements including height,weight and waist circumference were also taken for each individual.

Participants were then invited back to repeat follistatin levels.

Conditions

Obesity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

metabolically healthy individuals with obesity

Individuals with BMI ≥30 , those without criteria of metabolic syndrome other than an increase in waist circumference (blood pressure ≥130/85 mmHg, fasting blood sugar ≥100 mg/dl, triglycerides ≥150 mg/dl, HDL-cholesterol \<40 mg/dl in men and \<50 mg/dl in women) and without prediabetes

Serum follistatin levels

Intervention Type: DIAGNOSTIC_TEST

blood samples are taken

metabolically unhealthy individuals with obesity

Individuals with BMI ≥30 , and have one of the followings: blood pressure ≥130/85 mmHg, fasting blood sugar ≥100 mg/dl, triglycerides ≥150 mg/dl, HDL-cholesterol \<40 mg/dl in men and \<50 mg/dl in women

Serum follistatin levels

Intervention Type: DIAGNOSTIC_TEST

blood samples are taken

Interventions

Serum follistatin levels

blood samples are taken

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Having given consent to the study
• Being over 18 years of age
• Being under 60 years of age
• Body mass index >=30 kg/m2

Exclusion Criteria

• Antidiabetic medication usage
• obesity surgery
• Antihypertensive medication usage
• Those receiving lipid-lowering therapy
• Pregnant women
• Those with hypo/hyperthyroidism
• Steroid use
• Benign/malignant tumors
• Advanced liver disease
• Secondary causes of obesity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Goztepe Prof Dr Suleyman Yalcın City Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ayse N Erbakan

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayşe N Erbakan, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Medeniyet University Goztepe Research and TRaining Hospital

Locations

Istanbul Medeniyet University Goztepe Research and TRaining Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Metabolic health-Follistatin

Identifier Type: -

Identifier Source: org_study_id